Becton Dickinson‘s (NYSE: BDX) life sciences division issued a recall last month for some of its blood collection tubes, citing a manufacturing flaw that resulted in devices without sufficient additive. The company explained that an internal investigation found that Vacutainer Citrate Plus tubes with too little additive led to falsely-shortened clotting time and could impact patient […]
Diagnostics
AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers
Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]
7 medtech stories we missed this week: April 6, 2018
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]
Curetis wins FDA nod for respiratory infection diagnostic system
Molecular diagnostics company Curetis said today that it won a de novo clearance from the FDA for its Unyvero System and lower respiratory tract infection cartridge. Combined with the cartridge, the Unyvero System evaluates samples for the presence of infectious respiratory disease in under five hours. The device can also tell doctors if it detects any genetic antibiotic resistance […]
Brainomix raises $10m for AI stroke imaging tech
Brainomix said today that it raised nearly $10 million for the e-ASPECTS stroke imaging technology it’s developing using artificial intelligence. The £7 million round was led by Parkwalk Advisors, joined by existing backers Chimera Partners and Oxford University Innovation Fund and the venture arm of pharma giant Boehringer Ingelheim. Oxford, England-based Brainomix said its tech is […]
Myriad’s breast cancer diagnostic wins approval in Japan
Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK). Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck are working to […]
Why partnerships between medtech companies and doctors are so important
As new devices and technologies are being developed in the medtech industry, doctors and physicians have to learn about the devices on platforms that are different from what they know. One way to help make the healthcare provider’s transition into using new devices easier is to forge a partnership between the industry and the physician, […]
Allina Health and Zipnosis partner to expand online care platform
Allina Health and Zipnosis have recently partnered to update Allina Health’s online diagnosis and treatment service. Allina Health recently launched its Everyday Online platform that is powered by virtual care company Zipnosis. Allina Health Everyday Online is designed to bring convenient access to patients through Minnesota and Western Wisconsin. Get the full story on our […]
T2 Biosystems touts results from 4 studies of its T2Dx diagnostics system
T2 Biosystems this week released results from four studies of its T2Dx blood diagnostics system designed to detect pathogens that cause sepsis, touting clinical and performance advantages when compared to traditional blood cultures. The four studies were published in the Journal of Antimicrobial Chemotherapy, the Lexington, Mass.-based company said. A study conducted at Rome’s Gemelli Hospital […]
Foundation Medicine launches genomic profiling test for solid tumors
Foundation Medicine (NSDQ:FMI) today launched the first FDA-approved comprehensive genomic profiling assay for all solid tumors in the U.S. The test, FoundationOne CDx, is designed to detect specific genomic alterations and help doctors make personalized treatment decisions for their patients. Get the full story at our sister site, Drug Delivery Business News.
Abbott launches new CardioMems trial
Abbott (NYSE:ABT) said today it launched a new trial of its CardioMems HF implantable cardiac monitoring system, exploring the device’s ability to improve survival and quality of life for people with New York Heart Association Class II to Class IV heart failure. The study, dubbed the Guide-HF trial, is slated to enroll a total of 3,600 […]